Auditory-somatosensory Stimulation to Alleviate Tinnitus

NCT ID: NCT02974543

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-06-30

Brief Summary

The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.

Detailed Description

This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.

The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sham 1st (Auditory only) then Active (Bimodal)

To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.

During active treatment, the device will deliver electric somatosensory and auditory stimulation.

Group Type: OTHER

Sham Treatment: unimodal auditory stimulation

Intervention Type: DEVICE

All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.

Active Treatment: Bimodal auditory-somatosensory stimulation

Intervention Type: DEVICE

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

Active (Bimodal) then Sham (Auditory only)

During active treatment, the device will deliver electric somatosensory and auditory stimulation.

To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.

Group Type: OTHER

Sham Treatment: unimodal auditory stimulation

Intervention Type: DEVICE

All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.

Active Treatment: Bimodal auditory-somatosensory stimulation

Intervention Type: DEVICE

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

Interventions

Sham Treatment: unimodal auditory stimulation

All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.

Intervention Type: DEVICE

Active Treatment: Bimodal auditory-somatosensory stimulation

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.

2. Hearing thresholds better than 50dB HL at peak tinnitus frequencies.

3. Able to modulate their tinnitus with a somatic maneuver

4. BothersomeTinnitus.

Exclusion Criteria

• No participation in a tinnitus treatment regimen within the past four weeks
• Retrocochlear pathology/ VIIIth nerve lesion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wallace H Coulter Center for Translational Research

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Susan E. Shore

Professor, Otolaryngology, Molecular and Integrative Physiology; Professor, Biomedical Engineering Kresge Hearing Research Institute The Joseph Hawkins Collegiate Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Shore, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Kresge Hearing Research Institute

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00088432

Identifier Type: -

Identifier Source: org_study_id